Episode description
This is audio from RQM+ Live! #62, recorded 3 November, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website.
Most of us have used standards in some shape or form. There are those that assume they know all about standards, and those who think, “Ugh, standards are so boring.” Yet, how many people actually love standards? How many people always ask, “Is there a standard for this?” We do at RQM+.
The consideration and application of standards is a foundational element across the majority of MedTech product lifecycle activities and can provide a clear route to compliance when used well.
Our panelists will discuss key elements of implementing standards and shine light on dark and often misunderstood corners of the world of standards.
Elements discussed include:
- What do we mean when we talk about standards?
- What is the difference between state of the art and the standard of care?
- Where do standards belong within the regulatory ecosystem?
- How can we use standards effectively throughout the product lifecycle?
Panelists:
- Smirthwaite, BEng, Ph.D. – Senior Vice President, Intelligence & Innovation
- Carlos Galamba, MSc – Vice President, Intelligence & Innovation - IVD
- Sally Sennitt, MBBS, FRCA – Medical Director
- Ed Ball, CEng MIPEM MIMMM – Intelligence & Strategic Execution Manager
- Rem Siekmann, CMDA, RAC – Senior Principal Engineer/Auditor
Questions with timestamps:
3:42 -- Brief introduction and what do we mean by State of the Art?
12:25 -- How do you establish State of the Art? Should we not create a State of the Art generic standard that recommends companies look elsewhere for State of the Art? Standards, common specifications, trends, etc.
16:37 -- How do you establish what expected outcomes, performance, or design specifications for a product?
21:04 -- Standard of care can usually lag behind technology and practical clinical development. For example, NICE guidelines defines success in hip replacements as a revision rate of 5% or less at 10 years, however, the best prosthesis usually have revision rates of 1-2% at the same stage. Shouldn't state of the art be defined in this case as the gold standard rather than pull towards the average?
29:55 -- When you say stratify by patient population what are the variables we should stratify by? Is it by patient population age, existing health condition, etc.?
33:35 -- What are you seeing in terms of requirements from notified bodies? Are you seeing consistencies or best practices?
43:06 -- How is the State of the Art defined for SaMD/MDSW, especially those without a specific clinical indication (e.g. Class A IVD SaMD)?
46:36 -- For clinical evaluation of custom made (vascular) devices, does it make sense to compare to SotA data on alternative treatments to confirm safety and performance? Considering alternative treatments have generally be ruled out for these patients if a custom made device is being considered.
55:14 -- How do you suggest to approach areas with several standards/guidances published addressing things that more or less overlap - e.g. cybersecurity?
1:00:48 -- What is your best tip or your best piece of advice?